Safety Alerts & Recalls

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FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis
The U.S. Food and Drug Administration (FDA) is alerting people with MS to the risks of serious injuries and death associated with the experimental procedure sometimes called “liberation therapy” or the “liberation procedure" to treat chronic cerebrospinal venous insufficiency (CCSVI). The benefits of these experimental procedures have not been proven, and their promotion as a treatment for MS may lead people with the disease to make treatment decisions without being aware of the serious risks involved. The underlying cause of MS is not known. Some researchers think that narrowing (stenosis) of specific veins in the neck and chest (internal jugular and azygos veins) may cause MS or may contribute to the progression of MS by impairing blood drainage from the brain and upper spinal cord. This narrowing of neck and chest veins has been called CCSVI. Some individuals, organizations, and websites promote "liberation therapy" or the "liberation procedure" which is an experimental treatment that uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death; stroke; detachment and migration of the stents; damage to the treated vein; blood clots; cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI. Studies exploring a link between MS and CCSVI are inconclusive. Some studies have suggested a link exists, while others have found no such connection. At this time, the FDA believes there is no reliable evidence from controlled clinical trials that the experimental procedure is effective in treating MS. In addition, the criteria used to diagnose CCSVI have not been adequately established. For more information, please visit: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm303318.htm
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FDA Completes Safety Review of Cancer Drug Revlimid (lenalidomide) and Risk of Developing New Types of Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of developing a new types of cancer in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed multiple myeloma patients treated with Revlimid had an increased risk of developing a second new type of cancer compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma. This safety information has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk. Revlimid contains the active ingredient lenalidomid. Revlimid is a prescription medicine used to treat patients with multiple myeloma (a type of cancer of the bone marrow) who already have had prior therapy. Revlimid is also approved to treat patients who have certain types of myelodysplastic syndromes (a group of conditions in which the bone marrow does not produce enough mature blood cells) For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm302939.htm
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Date Published Title Drug Source
2012-05-11 FDA Warns on Dangers of Unproven Treatment for Multiple Sclerosis FDA
2012-05-07 FDA Completes Safety Review of Cancer Drug Revlimid (lenalidomide) and Risk of Developing New Types of Cancers Lenalidomide FDA
2012-05-06 Novartis Consumer Health Recalls Excedrin, NoDoz, Bufferin, and Gas-X Prevention Products Manufacturer
2012-05-01 Vintage Pharmaceuticals Recalls Single Lots of Methylprednisolone, Tablets, 4 mg Methylprednisolone FDA
2012-05-01 Teva Pharmaceuticals USA Recalls Single Lot of Claravis 40 mg Isotretinoin FDA
2012-05-01 Actavis Totowa LLC Recalls Select Lots of Losartan Potassium Tablets, 50 mg Losartan FDA
2012-05-01 Teva Pharmaceuticals USA Recalls Single Lot of Mefloquine Tablets, 250mg Mefloquine FDA
2012-05-01 Quadrant Chemical Corporation Recalls Single Lot of DermaZinc Spray, (zinc pyritione) 0.25% Dermazinc FDA
2012-05-01 Apotex Inc. Recalls Single Lot of Cyclosporine Oral Solution, USP (modified), 100 mg/mL Cyclosporine FDA
2012-05-01 Schering-Plough Products Recalls Single Lot of Temodar (temozolomide capsules), 5 mg Temozolomide FDA
2012-05-01 Medtech Products, Inc. Recalls Several Lots of Pedia Care Infants Gas Relief Drops (Simethicone) Simethicone FDA
2012-05-01 Mylan Pharmaceuticals Inc. Recalls Several Lots of Morphine Sulfate ER Tablets, 200 mg Morphine FDA
2012-04-27 Recall of several lots of Good Neighbor Pharmacy, Night Time Liquid Caps Acetaminophen with Dextromethorphan and Doxylamine FDA
2012-04-27 Bayer Healthcare Recalls Select Lots of Alka-Seltzer Plus, Severe Sinus Congestion, Allergy & Cough Formula FDA
2012-04-27 Sandoz Incorporated Recalls Select Lots of Pramipexole Dihydrochloride Tablets, 0.125 mg Pramipexole FDA
2012-04-27 Updated information on drug interactions for Victrelis (boceprevir) Boceprevir FDA
2012-04-23 FDA Announces New Warning and Contraindications for Aliskiren-containing Medications Aliskiren FDA
2012-04-19 Important Information for the Safe Use of Fentanyl Patches Fentanyl FDA
2012-04-16 Novartis Issues Safety Information Update Gilenya (fingolimod) Fingolimod Manufacturer
2012-04-13 FDA Updates Prescribing Information for Finasteride (Propecia, Proscar) Finasteride FDA
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